DHA and EPA - Maintenance of Normal Brain Function

EFSA Journal 2011;9(4):2078
SCIENTIFIC OPINION
Scientific Opinion on the substantiation of health claims related to

docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and brain, eye
and nerve development (ID 501, 513, 540), maintenance of normal brain
function (ID 497, 501, 510, 513, 519, 521, 534, 540, 688, 1323, 1360, 4294),
maintenance of normal vision (ID 508, 510, 513, 519, 529, 540, 688, 2905,
4294), maintenance of normal cardiac function (ID 510, 688, 1360),
“maternal health; pregnancy and nursing” (ID 514), “to fulfil increased
omega-3 fatty acids need during pregnancy” (ID 539), “skin and digestive
tract epithelial cells maintenance” (ID 525), enhancement of mood (ID 536),
“membranes cell structure” (ID 4295), “anti-inflammatory action”
(ID 4688) and maintenance of normal blood LDL-cholesterol
concentrations (ID 4719) pursuant to Article 13(1) of Regulation (EC) No
1924/20061
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
SUMMARY
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and
Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of
Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims
1
On request from the European Commission, Question No EFSA-Q-2008-1284, EFSA-Q-2008-1288, EFSA-Q-2008-1295,
EFSA-Q-2008-1297, EFSA-Q-2008-1300, EFSA-Q-2008-1301, EFSA-Q-2008-1306, EFSA-Q-2008-1308, EFSA-Q-
2008-1312, EFSA-Q-2008-1316, EFSA-Q-2008-1321, EFSA-Q-2008-1323, EFSA-Q-2008-1326, EFSA-Q-2008-1327,
EFSA-Q-2008-1475, EFSA-Q-2008-2060, EFSA-Q-2008-2097, EFSA-Q-2008-3638, EFSA-Q-2010-00247, EFSA-Q-
2010-00248, EFSA-Q-2010-00641, EFSA-Q-2010-00672, adopted by written procedure on 17 February 2011.
2
Panel members: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen,
Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold,
Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé,
Hendrik van Loveren and Hans Verhagen. Correspondence: nda@efsa.europa.eu
3
Acknowledgement: The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the
Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina
Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz,
Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group
on Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter
Willatts.
Suggested citation: Scientific Opinion on the substantiation of health claims related to docosahexaenoic acid (DHA),
eicosapentaenoic acid (EPA) and brain, eye and nerve development (ID 501, 513, 540), maintenance of normal brain
function (ID 497, 501, 510, 513, 519, 521, 534, 540, 688, 1323, 1360, 4294), maintenance of normal vision (ID 508, 510,
513, 519, 529, 540, 688, 2905, 4294), maintenance of normal cardiac function (ID 510, 688, 1360), “maternal health;
pregnancy and nursing” (ID 514), “to fulfil increased omega-3 fatty acids need during pregnancy” (ID 539), “skin and
digestive tract epithelial cells maintenance” (ID 525), enhancement of mood (ID 536), “membranes cell structure”
(ID 4295), “anti-inflammatory action” (ID 4688) and maintenance of normal blood LDL-cholesterol concentrations
(ID 4719) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4):2078 [30 pp.].
doi:10.2903/j.efsa.2011.2078. Available online: www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2011

DHA/EPA related health claims
in relation to docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and brain, eye and nerve
development, maintenance of normal brain function, maintenance of normal vision, maintenance of
normal cardiac function, “maternal health; pregnancy and nursing”, “skin and digestive tract epithelial
cells maintenance”, enhancement of mood, “to fulfil increased omega-3 fatty acids need during
pregnancy”, “membranes cell structure”, “anti-inflammatory action” and maintenance of normal
blood LDL-cholesterol concentrations. The scientific substantiation is based on the information
provided by the Member States in the consolidated list of Article 13 health claims and references that
EFSA has received from Member States or directly from stakeholders.
The food constituent that is the subject of the health claims is long-chain n-3 polyunsaturated fatty
acids (n-3 LCPUFAs), namely docosahexaenoic acid (DHA) in combination with eicosapentaenoic
acid (EPA). The Panel considers that DHA and EPA are sufficiently characterised.
Brain, eye and nerve development
The claimed effects are “brain development, cognitive development and cognitive function”, “brain,
eye and nerve development and function”, and “support of human neurodevelopment”.
Brain, eye and nerve development is interpreted by the Panel as children’s development. The Panel
notes that claims related to children’s development and health are outside the scope of Article 13 of
Regulation (EC) No 1924/2006.
Maintenance of normal brain function

The claimed effects are “brain/cognitive function”, “brain development, cognitive development and
cognitive function”, “eye, brain and heart health”, “brain, eye and nerve development and function”,
“brain and eye function”, “brain function”, “n-3 are essential fatty acids and have critical roles in the
membrane structure and as precursors of eicosanoids”, “support of human neurodevelopment”, “eye,
brain and heart health”, “système nerveux, réduction des risques liés au dévelopement de la maladie
d'Alzheimer”, “health benefits of food: Dairygold Omega-3 spread contain omega- 3 fatty acids (EPA
& DHA) which may have a beneficial role to play in the functioning of the brain and can help
maintain a healthy heart”, and “membranes cell structure”. The target population is assumed to be the
general population. In the context of the proposed wordings and the clarifications provided, the Panel
assumes that the claimed effect refers to maintenance of normal brain function.
A claim on DHA and maintenance of normal brain function has already been assessed with a
favourable outcome.
Maintenance of normal vision

The claimed effects are “eye health”, “eye, brain and heart health”, “brain, eye and nerve development
and function”, “brain and eye function”, “support of human neurodevelopment”, “building block for
lipids in the retina’s photoreceptors; eye health”, and “membranes cell structure”. The target
population is assumed to be the general population. In the context of the proposed wordings and the
clarifications provided, the Panel assumes that the claimed effect refers to maintenance of normal
vision.
A claim on DHA and maintenance of normal vision has already been assessed with a favourable
outcome.
Maintenance of normal cardiac function
The claimed effects are “eye, brain and heart health”, and “health benefits of food: Dairygold Omega-
3 spread contain omega-3 fatty acids (EPA & DHA) which may have a beneficial role to play in the
functioning of the brain and can help maintain a healthy heart”. The target population is assumed to
be the general population.
EFSA Journal 2011;9(4):2078 2

A claim on DHA/EPA and maintenance of normal cardiac function has already been assessed with a
favourable outcome.
“Maternal health; pregnancy and nursing”
The claimed effect is “maternal health; pregnancy and nursing”. The Panel assumes that the target
population is pregnant and lactating women.
The claimed effect is not sufficiently defined, and no further details were provided in the proposed
wordings or the clarifications provided by Member States.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any
specific health claim as required by Regulation (EC) No 1924/2006.
“To fulfil increased omega-3 fatty acids need during pregnancy”
The claimed effect is “to fulfil increased omega-3 fatty acids need during pregnancy”. The Panel
assumes that the target population is pregnant and lactating women.
The Panel assumes that the claimed effect refers to the supply of omega-3 fatty acids to the body
during pregnancy and lactation. The Panel considers that the claimed effect refers to the supply of a
food constituent to the human body, rather than to a relationship between a food/food constituent and
health as required by Regulation (EC) No 1924/2006.
“Skin and digestive tract epithelial cells maintenance”
The claimed effect is “skin and digestive tract epithelial cells maintenance”. The target population is
assumed to be the general population.
The claimed effect is not sufficiently defined. The proposed wordings do not provide further
clarification or do not refer to a physiological function; the clarifications provided by Member States
include several physiological functions; and the references provided did not allow the identification of
the specific function which is the target for the claim.
Enhancement of mood
The claimed effect is “mood”. The target population is assumed to be the general population. In the
context of the clarifications provided, the Panel assumes that the claimed effect refers to enhancement
of mood. The Panel considers that enhancement of mood might be a beneficial physiological effect.
No intervention studies were provided from which conclusions could be drawn for the scientific
substantiation of the claimed effect, and one observational study showed no association between the
consumption of DHA/EPA and mood.
On the basis of the data presented, the Panel concludes that a cause and effect relationship has not
been established between the consumption of DHA/EPA and enhancement of mood.
“Membranes cell structure”
The claimed effect is “membranes cell structure”. The target population is assumed to be the general
population.
EFSA Journal 2011;9(4):2078 3

clarification, and from the references provided it was not possible to establish which effect is the
target for the claim.
“Anti-inflammatory action”
From the proposed wordings, the Panel assumes that the claimed effect refers to anti-inflammatory
action in the context of “inflammatory, rheumatic disease”, in which a reduction of inflammation
would be a therapeutic target for the treatment of the disease.
The Panel considers that the reduction of inflammation in the context of inflammatory diseases is a
therapeutic target for the treatment of a disease, and does not comply with the criteria laid down in
Maintenance of normal blood LDL-cholesterol concentrations
The claimed effect is “blood health”. The target population is assumed to be the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the
maintenance of normal blood LDL-cholesterol concentrations.
A claim on DHA and EPA and maintenance of normal blood LDL-cholesterol concentrations has
already been assessed with an unfavourable outcome. The references cited for this claim did not
provide any additional scientific data which could be used to substantiate the claim.
KEY WORDS
Docosahexaenoic acid, DHA, eicosapentaenoic acid, EPA, cardiac function, brain, vision, mood,
LDL-cholesterol, health claims.
EFSA Journal 2011;9(4):2078 4

TABLE OF CONTENTS
Summary .................................................................................................................................................. 1
Table of contents ...................................................................................................................................... 5
Background as provided by the European Commission .......................................................................... 6
Terms of reference as provided by the European Commission ............................................................... 6
EFSA Disclaimer...................................................................................................................................... 6
Information as provided in the consolidated list ...................................................................................... 7
Assessment ............................................................................................................................................... 7
1. Characterisation of the food/constituent ........................................................................................ 7
2. Relevance of the claimed effect to human health .......................................................................... 7
2.1. Brain, eye and nerve development (ID 501, 513, 540) ........................................................... 7
2.2. Maintenance of normal brain function (ID 497, 501, 510, 513, 519, 521, 534, 540, 688,
1323, 1360, 4294) .................................................................................................................. 7
2.3. Maintenance of normal vision (ID 508, 510, 513, 519, 529, 540, 688, 2905, 4294) ............. 8
2.4. Maintenance of normal cardiac function (ID 510, 688, 1360) ............................................... 8
2.5. “Maternal health; pregnancy and nursing” (ID 514) .............................................................. 8
2.6. “To fulfil increased omega-3 fatty acids need during pregnancy” (ID 539) .......................... 8
2.7. “Skin and digestive tract epithelial cells maintenance” (ID 525) ........................................... 9
2.8. Enhancement of mood (ID 536) ............................................................................................. 9
2.9. “Membranes cell structure” (ID 4295) ................................................................................... 9
2.10. “Anti-inflammatory action” (ID 4688) ................................................................................... 9
2.11. Maintenance of normal blood LDL-cholesterol concentrations (ID 4719) .......................... 10
3. Scientific substantiation of the claimed effect ............................................................................. 10
3.1. Enhancement of mood (ID 536) ........................................................................................... 10
Conclusions ............................................................................................................................................ 11
Documentation provided to EFSA ......................................................................................................... 13
References .............................................................................................................................................. 14
Appendices ............................................................................................................................................. 16
Glossary and Abbreviations ................................................................................................................... 30
EFSA Journal 2011;9(4):2078 5

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

See Appendix A
TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

See Appendix A
EFSA DISCLAIMER
See Appendix B
EFSA Journal 2011;9(4):2078 6

INFORMATION AS PROVIDED IN THE CONSOLIDATED LIST

The consolidated list of health claims pursuant to Article 13 of Regulation EC (No) 1924/20064
submitted by Member States contains main entry claims with corresponding conditions of use and
literature for similar health claims. EFSA has screened all health claims contained in the original
consolidated list of Article 13 health claims which was received by EFSA in 2008 using six criteria
established by the NDA Panel to identify claims for which EFSA considered sufficient information
had been provided for evaluation and those for which more information or clarification was needed
before evaluation could be carried out5. The clarifications which were received by EFSA through the
screening process have been included in the consolidated list. This additional information will serve
as clarification to the originally provided information. The information provided in the consolidated
list for the health claims which are the subject of this opinion is tabulated in Appendix C.
ASSESSMENT
1. Characterisation of the food/constituent

The food constituent that is the subject of the health claims is long-chain n-3 polyunsaturated fatty
acids (n-3 LCPUFAs), namely docosahexaenoic acid (DHA) in combination with eicosapentaenoic
acid (EPA).
The n-3 LCPUFAs, EPA and DHA, are well recognised nutrients and are measurable in foods by
established methods. They are well absorbed when consumed in the form of triglycerides. This
evaluation applies to EPA and DHA from all sources with appropriate bioavailability in the specified
amounts.
The Panel considers that the food constituent, DHA and EPA, which is the subject of the health
claims, is sufficiently characterised.
2. Relevance of the claimed effect to human health
2.1. Brain, eye and nerve development (ID 501, 513, 540)
The claimed effects are “brain development, cognitive development and cognitive function”, “brain,
eye and nerve development and function”, and “support of human neurodevelopment”.
Brain, eye and nerve development is interpreted by the Panel as children’s development. The Panel
notes that claims related to children’s development and health are outside the scope of Article 13 of
2.2. Maintenance of normal brain function (ID 497, 501, 510, 513, 519, 521, 534, 540, 688,
1323, 1360, 4294)
The claimed effects are “brain/cognitive function”, “brain development, cognitive development and
cognitive function”, “eye, brain and heart health”, “brain, eye and nerve development and function”,
“brain and eye function”, “brain function”, “n-3 are essential fatty acids and have critical roles in the
membrane structure and as precursors of eicosanoids”, “support of human neurodevelopment”, “eye,
4
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and
health claims made on foods. OJ L 404, 30.12.2006, p. 9–25.
5
Briefing document for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims:
http://www.efsa.europa.eu/en/ndameetings/docs/nda100601-ax01.pdf
EFSA Journal 2011;9(4):2078 7

brain and heart health”, “système nerveux, réduction des risques liés au dévelopement de la maladie
d'Alzheimer”, “health benefits of food: Dairygold Omega-3 spread contain omega- 3 fatty acids (EPA
& DHA) which may have a beneficial role to play in the functioning of the brain and can help
maintain a healthy heart”, and “membranes cell structure”. The Panel assumes that the target
population is the general population. In the context of the proposed wordings and the clarifications
provided, the Panel assumes that the claimed effects refer to the maintenance of normal brain
function.
favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).
2.3. Maintenance of normal vision (ID 508, 510, 513, 519, 529, 540, 688, 2905, 4294)
The claimed effects are “eye health”, “eye, brain and heart health”, “brain, eye and nerve development
and function”, “brain and eye function”, “support of human neurodevelopment”, “building block for
lipids in the retina’s photoreceptors; eye health”, and “membranes cell structure”. The Panel assumes
that the target population is the general population. In the context of the proposed wordings and the
clarifications provided, the Panel assumes that the claimed effects refer to the maintenance of normal
vision.
A claim on DHA and maintenance of normal vision has already been assessed with a favourable
outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).
2.4. Maintenance of normal cardiac function (ID 510, 688, 1360)

The claimed effects are “eye, brain and heart health”, and “health benefits of food: Dairygold
Omega-3 spread contain omega- 3 fatty acids (EPA & DHA) which may have a beneficial role to play
in the functioning of the brain and can help maintain a healthy heart”. The Panel assumes that the
target population is the general population. The Panel notes that the claimed effects refer to the
maintenance of normal cardiac function.
A claim on DHA and EPA and maintenance of normal cardiac function has already been assessed
with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).
2.5. “Maternal health; pregnancy and nursing” (ID 514)

The claimed effect is “maternal health; pregnancy and nursing”. The Panel assumes that the target
population is pregnant and lactating women.
The claimed effect is not sufficiently defined, and no further details were given in the proposed
wording or the clarifications provided by Member States.
2.6. “To fulfil increased omega-3 fatty acids need during pregnancy” (ID 539)
The claimed effect is “to fulfil increased omega-3 fatty acids need during pregnancy”. The Panel
assumes that the target population is pregnant and lactating women.
The Panel assumes that the claimed effect refers to the supply of omega-3 fatty acids to the body
during pregnancy and lactation.
EFSA Journal 2011;9(4):2078 8

The Panel considers that the claimed effect refers to the supply of a food constituent to the human
body, rather than to a relationship between a food/food constituent and health as required by
2.7. “Skin and digestive tract epithelial cells maintenance” (ID 525)
The claimed effect is “skin and digestive tract epithelial cells maintenance”. The Panel assumes that
the target population is the general population.
clarification (“a healthy digestive system, gentle on the stomach”) or do not refer to a physiological
function (“appearance of skin, healthy looking skin, a part of your daily skin care routine, helps
maintain a good complexion”) as required by Regulation (EC) No 1924/2006. The clarifications
provided by Member States include several physiological functions, and the references provided do
not allow the identification of the specific function which is the target for the claim.
2.8. Enhancement of mood (ID 536)

The claimed effect is “mood”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided, the Panel assumes that the claimed effect refers to
enhancement of mood. Mood is a well-defined psychological construct and can be measured by
validated tests.
The Panel considers that enhancement of mood might be a beneficial physiological effect.
2.9. “Membranes cell structure” (ID 4295)

The claimed effect is “membranes cell structure”. The Panel assumes that the target population is the
general population.
The claimed effect is not sufficiently defined. The proposed wordings did not provide further
clarification (“contributes to thin the blood”), and from the references provided it was not possible to
establish the effect which was the target for the claim.
specific effect on health as required by Regulation (EC) No 1924/2006.
2.10. “Anti-inflammatory action” (ID 4688)

The claimed effect is “anti-inflammatory action due to EPA and DHA”. The Panel assumes that the
target population is the general population.
From the proposed wordings, the Panel assumes that the claimed effect refers to anti-inflammatory
action in the context of “inflammatory, rheumatic disease”, in which a reduction of inflammation
would be a therapeutic target for the treatment of the disease.
The Panel considers that the reduction of inflammation in the context of inflammatory diseases is a
therapeutic target for the treatment of a disease, and does not comply with the criteria laid down in
EFSA Journal 2011;9(4):2078 9

2.11. Maintenance of normal blood LDL-cholesterol concentrations (ID 4719)

The claimed effect is “blood health”. The Panel assumes that the target population is the general
population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the
maintenance of normal blood LDL-cholesterol concentrations.
A claim on DHA and EPA and maintenance of normal blood LDL-cholesterol concentrations has
already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and
Allergies (NDA), 2009). The references cited for this claim did not provide any additional scientific
data which could be used to substantiate the claim.
3. Scientific substantiation of the claimed effect
3.1. Enhancement of mood (ID 536)

Among the references provided were narrative reviews which mostly reported on the use of omega-3
fatty acids either alone or in conjunction with pharmacological intervention in depression. These
studies did not describe the food constituent under investigation or did not address a relevant
endpoint. In addition, a number of references reported on studies which were carried out in pregnant
women or in patient groups with post-partum depression, major depressive disorder which required
inpatient treatment, violence disorders, bipolar disorder and schizophrenia. The Panel considers that
the evidence provided does not establish that results obtained in studies in subjects with post-partum
depression, major depressive disorder, violence disorders, bipolar disorder and schizophrenia can be
extrapolated to the general population with respect to mood. The Panel considers that no conclusions
can be drawn from these references for the scientific substantiation of the claimed effect.
One systematic review carried out by Schachter et al. (2005) for the Agency for Healthcare Research
and Quality (AHRQ) addressed, inter alia, the question of the protective value of n-3 fatty acids with
respect to mental health. Three intervention studies, six observational studies and three cross-national
ecological studies met the authors’ inclusion criteria, and were included in the review. One of the
randomised controlled trials assessed the risk of post-partum depression using a supplement
containing DHA only, rather than DHA and EPA which is the subject of the claim. The other two
intervention studies were based on a dietary change to increase fish consumption, but DHA and EPA
intakes were not measured. There were four observational studies on the relationship between fish
consumption and depressed mood or prevalence of depression, and three cross-national studies
investigating the association of seafood consumption with the prevalence of post-partum depression
or depression. The Panel notes that the only epidemiological study in the systematic review, which
calculated DHA and EPA intakes on the basis of self-reported fish consumption, showed no
association between intake of these fatty acids and prevalence of depression.
Two of the human studies provided were intervention studies (Fontani et al., 2005a; 2005b). One of
these studies (Fontani et al., 2005a) investigated the effects of diet and fish oil (containing EPA and
DHA) supplementation on an index of mood state in addition to blood lipids, insulin and various
biomarkers of inflammatory processes. This study was performed in 33 subjects who were divided
into two groups following an open-label, parallel group design. Both groups followed a controlled diet
which differed in amount of carbohydrates and proteins (55/15 E% (N diet group, n=17) vs. 40/30 E%
(Z diet group, n=16) respectively, 30 E% fat in both). In each diet group a double-blind cross-over
design was applied: one sub-group received placebo (olive oil) for 35 days and then fish oil
supplementation for another 35 days, while the other sub-group started with fish oil supplementation
followed by placebo. Mood state was measured using the Profile of Mood States (POMS) which
consists of five negative scales (anger, anxiety, fatigue, confusion, depression) and one positive scale
EFSA Journal 2011;9(4):2078 10

(vigour). The Panel notes that the statistical analysis employed was not appropriate for the treatment
of a cross-over design, and that no corrections for multiple comparisons were made. The Panel
considers that no conclusions can be drawn from this reference for the scientific substantiation of the
claimed effect.
The other study by Fontani et al. (2005b) used a parallel design in which 33 subjects received EPA
and DHA as fish oil for 35 days, and a second group of 16 subjects received a placebo consisting of
olive oil capsules for the same period. Mood state was measured on the first and last day of the
intervention using the POMS. The Panel notes that the statistical analysis only evaluated within group
data, and did not perform comparisons between groups. The Panel considers that no conclusions can
be drawn from this study for the scientific substantiation of the claimed effect.
Of the three observational human studies provided, two (Edwards et al., 1998; Tanskanen et al., 2001)
were included in the systematic review by Schachter et al. (2005). The observational study by
Mamalakis et al. (2002) investigated the association between adipose tissue fatty acid content and
depression in 139 participants with a mean age of 39 years. Subjects underwent physical examination
and adipose tissue extraction (by aspiration of subcutaneous tissue samples), and completed the
Zung Self-rated Depression Scale (translated). The Panel notes that dietary intakes of EPA and DHA
were not estimated, that adipose tissue EPA and DHA concentrations are usually only moderately
associated with the consumption of EPA and DHA, and that an observational cross-sectional study
does not provide evidence on a causal relationship between the intake of DHA and EPA and mood.
The Panel considers that no conclusions can be drawn from this reference for the scientific
substantiation of the claimed effect.
The Panel notes that no intervention studies were provided from which conclusions could be drawn
for the scientific substantiation of the claimed effect, and that the one observational study which
evaluated dietary intakes of EPA and DHA showed no association between the consumption of DHA
and EPA and prevalence of depression.
The Panel concludes that a cause and effect relationship has not been established between the
consumption of DHA and EPA and enhancement of mood.
CONCLUSIONS
On the basis of the data presented, the Panel concludes that:
The food constituent, DHA and EPA, which is the subject of the health claims, is sufficiently
characterised.
Brain, eye and nerve development (ID 501, 513, 540)
The claimed effects are “brain development, cognitive development and cognitive function”,
“brain, eye and nerve development and function”, and “support of human
neurodevelopment”. Brain, eye and nerve development is interpreted as children’s
development.
Claims related to children’s development and health are outside the scope of Article 13 of
Maintenance of normal brain function (ID 497, 501, 510, 513, 519, 521, 534, 540, 688, 1323,
1360, 4294)
The claimed effects are “brain/cognitive function”, “brain development, cognitive

development and cognitive function”, “eye, brain and heart health”, “brain, eye and nerve
EFSA Journal 2011;9(4):2078 11
development and function”, “brain and eye function”, “brain function”, “n-3 are essential
fatty acids and have critical roles in the membrane structure and as precursors of
eicosanoids”, “support of human neurodevelopment”, “eye, brain and heart health”, “système
nerveux, réduction des risques liés au dévelopement de la maladie d'Alzheimer”, “health
benefits of food: Dairygold Omega-3 spread contain omega- 3 fatty acids (EPA & DHA)
which may have a beneficial role to play in the functioning of the brain and can help
maintain a healthy heart”, and “membranes cell structure”. The target population is assumed
to be the general population.
favourable outcome.
Maintenance of normal vision (ID 508, 510, 513, 519, 529, 540, 688, 2905, 4294)
The claimed effects are “eye health”, “eye, brain and heart health”, “brain, eye and nerve
development and function”, “brain and eye function”, “support of human
neurodevelopment”, “building block for lipids in the retina’s photoreceptors; eye health”,
and “membranes cell structure”. The target population is assumed to be the general
population.
A claim on DHA and maintenance of normal vision has already been assessed with a
favourable outcome.
Maintenance of normal cardiac function (ID 510, 688, 1360)
The claimed effects are “eye, brain and heart health”, and “health benefits of food: Dairygold
Omega-3 spread contain omega-3 fatty acids (EPA & DHA) which may have a beneficial
role to play in the functioning of the brain and can help maintain a healthy heart”. The target
population is assumed to be the general population.
A claim on DHA and EPA and maintenance of normal cardiac function has already been
assessed with a favourable outcome.
“Maternal health; pregnancy and nursing” (ID 514)
The claimed effect is “maternal health; pregnancy and nursing”. The target population is
assumed to be pregnant and lactating women.
The claimed effect is general and non-specific, and does not refer to any specific health
claim as required by Regulation (EC) No 1924/2006.
“To fulfil increased omega-3 fatty acids need during pregnancy” (ID 539)
The claimed effect is “to fulfil increased omega-3 fatty acids need during pregnancy”. The
Panel assumes that the target population is pregnant and lactating women. It is assumed that
the claimed effect refers to the supply of omega-3 fatty acids to the body during pregnancy
and lactation.
The claimed effect refers to the supply of a food constituent to the human body rather than to
a relationship between a food/food constituent and health as required by Regulation (EC) No
1924/2006.
EFSA Journal 2011;9(4):2078 12

“Skin and digestive tract epithelial cells maintenance” (ID 525)

The claimed effect is “skin and digestive tract epithelial cells maintenance”. The target
population is assumed to be the general population.
Enhancement of mood (ID 536)
The claimed effect is “mood”. The target population is assumed to be the general population.
Enhancement of mood might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of DHA
and EPA and enhancement of mood.
“Membranes cell structure” (ID 4295)

The claimed effect is “membranes cell structure”. The target population is assumed to be the
general population.
“Anti-inflammatory action” (ID 4688)

The claimed effect is “anti-inflammatory action due to EPA and DHA”. The target
population is assumed to be the general population. From the proposed wordings, the Panel
assumes that the claimed effect refers to anti-inflammatory action in the context of
“inflammatory, rheumatic disease”, in which a reduction of inflammation would be a
therapeutic target for the treatment of the disease.
Reduction of inflammation in the context of inflammatory diseases is a therapeutic target for

the treatment of a disease, and does not comply with the criteria laid down in Regulation
(EC) No 1924/2006.
Maintenance of normal blood LDL-cholesterol concentrations (ID 4719)

The claimed effect is “blood health”. The target population is assumed to be the general
population.
A claim on DHA and EPA and maintenance of normal blood LDL-cholesterol concentrations
has already been assessed with an unfavourable outcome. The references cited for this claim
did not provide any additional scientific data which could be used to substantiate the claim.
DOCUMENTATION PROVIDED TO EFSA

Health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 (No: EFSA-Q-2008-1284,
EFSA-Q-2008-1288, EFSA-Q-2008-1295, EFSA-Q-2008-1297, EFSA-Q-2008-1300, EFSA-Q-2008-
1301, EFSA-Q-2008-1306, EFSA-Q-2008-1308, EFSA-Q-2008-1312, EFSA-Q-2008-1316, EFSA-Q-
2008-1321, EFSA-Q-2008-1323, EFSA-Q-2008-1326, EFSA-Q-2008-1327, EFSA-Q-2008-1475,
EFSA-Q-2008-2060, EFSA-Q-2008-2097, EFSA-Q-2008-3638, EFSA-Q-2010-00247, EFSA-Q-2010-
00248, EFSA-Q-2010-00641, EFSA-Q-2010-00672). The scientific substantiation is based on the
information provided by the Member States in the consolidated list of Article 13 health claims and
references that EFSA has received from Member States or directly from stakeholders.
EFSA Journal 2011;9(4):2078 13

The full list of supporting references as provided to EFSA is available on:

http://www.efsa.europa.eu/panels/nda/claims/article13.htm.
REFERENCES
Edwards R, Peet M, Shay J and Horrobin D, 1998. Omega-3 polyunsaturated fatty acid levels in the
diet and in red blood cell membranes of depressed patients. Journal of Affective Disorders, 48,
149-155.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009. Scientific Opinion on the
substantiation of health claims related to EPA, DHA, DPA and maintenance of normal blood
pressure (ID 502), maintenance of normal HDL-cholesterol concentrations (ID 515), maintenance
of normal (fasting) blood concentrations of triglycerides (ID 517), maintenance of normal LDL-
cholesterol concentrations (ID 528, 698) and maintenance of joints (ID 503, 505, 507, 511, 518,
524, 526, 535, 537) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal,
7(9):1263, 26 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a. Scientific Opinion on the
substantiation of health claims related to eicosapentaenoic acid (EPA), docosahexaenoic acid
(DHA), docosapentaenoic acid (DPA) and maintenance of normal cardiac function (ID 504, 506,
516, 527, 538, 703, 1128, 1317, 1324, 1325), maintenance of normal blood glucose concentrations
(ID 566), maintenance of normal blood pressure (ID 506, 516, 703, 1317, 1324), maintenance of
normal blood HDL-cholesterol concentrations (ID 506), maintenance of normal (fasting) blood
concentrations of triglycerides (ID 506, 527, 538, 1317, 1324, 1325), maintenance of normal blood
LDL-cholesterol concentrations (ID 527, 538, 1317, 1325, 4689), protection of the skin from
photo-oxidative (UV-induced) damage (ID 530), improved absorption of EPA and DHA (ID 522,
523), contribution to the normal function of the immune system by decreasing the levels of
eicosanoids, arachidonic acid-derived mediators and pro-inflammatory cytokines (ID 520, 2914),
and “immunomodulating agent” (4690) pursuant to Article 13(1) of Regulation (EC) No
1924/2006. EFSA Journal, 8(10):1796, 32 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b. Scientific Opinion on the
substantiation of health claims related to docosahexaenoic acid (DHA) and maintenance of normal
(fasting) blood concentrations of triglycerides (ID 533, 691, 3150), protection of blood lipids from
oxidative damage (ID 630), contribution to the maintenance or achievement of a normal body
weight (ID 629), brain, eye and nerve development (ID 627, 689, 704, 742, 3148, 3151),
maintenance of normal brain function (ID 565, 626, 631, 689, 690, 704, 742, 3148, 3151),
maintenance of normal vision (ID 627, 632, 743, 3149) and maintenance of normal spermatozoa
motility (ID 628) pursuant to Article 13(3) of Regulation (EC) No 1924/2006. EFSA Journal,
8(10):1734, 27 pp.
Fontani G, Corradeschi F, Felici A, Alfatti F, Bugarini R, Fiaschi AI, Cerretani D, Montorfano G,
Rizzo AM and Berra B, 2005a. Blood profiles, body fat and mood state in healthy subjects on
different diets supplemented with Omega-3 polyunsaturated fatty acids. European Journal of
Clinical Investigation, 35, 499-507.
Fontani G, Corradeschi F, Felici A, Alfatti F, Migliorini S and Lodi L, 2005b. Cognitive and
physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects.
European Journal of Clinical Investigation, 35, 691-699.
Mamalakis G, Tornaritis M and Kafatos A, 2002. Depression and adipose essential polyunsaturated
fatty acids. Prostaglandins Leukotrienes and Essential Fatty Acids, 67, 311-318.
Schachter HM, Kourad K, Merali Z, Lumb A, Tran K, Miguelez M, Lewin G, Sampson M,
Barrowman N, Senechal H, McGahern C, Zhang L, Morrison A, Shlik J, Pan Y, Lowcock EC,
Gaboury I, Bradwejn J and Duffy A, 2005. Effects of Omega-3 Fatty Acids on Mental Health. 116,
Evidence Report/Technology Assessment No. 116. (Prepared by the University of Ottawa
EFSA Journal 2011;9(4):2078 14

Evidence-based Practice Center, Under Contract No. 290-02-0021.) AHRQ Publication No. 05-
E022-2. Rockville, MD: Agency for Healthcare Research and Quality.
Tanskanen A, Hibbeln JR, Tuomilehto J, Uutela A, Haukkala A, Viinamaki H, Lehtonen J and
Vartiainen E, 2001. Fish consumption and depressive symptoms in the general population in
Finland. Psychiatric Services, 52, 529-531.
EFSA Journal 2011;9(4):2078 15

APPENDICES
APPENDIX A
BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

The Regulation (EC) No 1924/2006 on nutrition and health claims made on foods6 (hereinafter "the
Regulation") entered into force on 19th January 2007.
Article 13 of the Regulation foresees that the Commission shall adopt a Community list of permitted
health claims other than those referring to the reduction of disease risk and to children's development
and health. This Community list shall be adopted through the Regulatory Committee procedure and
following consultation of the European Food Safety Authority (EFSA).
Health claims are defined as "any claim that states, suggests or implies that a relationship exists
between a food category, a food or one of its constituents and health".
In accordance with Article 13 (1) health claims other than those referring to the reduction of disease
risk and to children's development and health are health claims describing or referring to:
a) the role of a nutrient or other substance in growth, development and the functions of the
body; or
b) psychological and behavioural functions; or
c) without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the
sense of hunger or an increase in the sense of satiety or to the reduction of the available
energy from the diet.
To be included in the Community list of permitted health claims, the claims shall be:
(i) based on generally accepted scientific evidence; and

(ii) well understood by the average consumer.
Member States provided the Commission with lists of claims as referred to in Article 13 (1) by 31
January 2008 accompanied by the conditions applying to them and by references to the relevant
scientific justification. These lists have been consolidated into the list which forms the basis for the
EFSA consultation in accordance with Article 13 (3).
ISSUES THAT NEED TO BE CONSIDERED
IMPORTANCE AND PERTINENCE OF THE FOOD7

Foods are commonly involved in many different functions8 of the body, and for one single food many
health claims may therefore be scientifically true. Therefore, the relative importance of food e.g.
nutrients in relation to other nutrients for the expressed beneficial effect should be considered: for
functions affected by a large number of dietary factors it should be considered whether a reference to
a single food is scientifically pertinent.
6
OJ L12, 18/01/2007
7
The term 'food' when used in this Terms of Reference refers to a food constituent, the food or the food category.
8
The term 'function' when used in this Terms of Reference refers to health claims in Article 13(1)(a), (b) and (c).
EFSA Journal 2011;9(4):2078 16

It should also be considered if the information on the characteristics of the food contains aspects
pertinent to the beneficial effect.
SUBSTANTIATION OF CLAIMS BY GENERALLY ACCEPTABLE SCIENTIFIC EVIDENCE

Scientific substantiation is the main aspect to be taken into account to authorise health claims. Claims
should be scientifically substantiated by taking into account the totality of the available scientific
data, and by weighing the evidence, and shall demonstrate the extent to which:
(a) the claimed effect of the food is beneficial for human health,
(b) a cause and effect relationship is established between consumption of the food and the
claimed effect in humans (such as: the strength, consistency, specificity, dose-
response, and biological plausibility of the relationship),
(c) the quantity of the food and pattern of consumption required to obtain the claimed
effect could reasonably be achieved as part of a balanced diet,
(d) the specific study group(s) in which the evidence was obtained is representative of the
target population for which the claim is intended.
EFSA has mentioned in its scientific and technical guidance for the preparation and presentation of
the application for authorisation of health claims consistent criteria for the potential sources of
scientific data. Such sources may not be available for all health claims. Nevertheless it will be
relevant and important that EFSA comments on the availability and quality of such data in order to
allow the regulator to judge and make a risk management decision about the acceptability of health
claims included in the submitted list.
The scientific evidence about the role of a food on a nutritional or physiological function is not
enough to justify the claim. The beneficial effect of the dietary intake has also to be demonstrated.
Moreover, the beneficial effect should be significant i.e. satisfactorily demonstrate to beneficially
affect identified functions in the body in a way which is relevant to health. Although an appreciation
of the beneficial effect in relation to the nutritional status of the European population may be of
interest, the presence or absence of the actual need for a nutrient or other substance with nutritional or
physiological effect for that population should not, however, condition such considerations.
Different types of effects can be claimed. Claims referring to the maintenance of a function may be
distinct from claims referring to the improvement of a function. EFSA may wish to comment whether
such different claims comply with the criteria laid down in the Regulation.
WORDING OF HEALTH CLAIMS

Scientific substantiation of health claims is the main aspect on which EFSA's opinion is requested.
However, the wording of health claims should also be commented by EFSA in its opinion.
There is potentially a plethora of expressions that may be used to convey the relationship between the
food and the function. This may be due to commercial practices, consumer perception and linguistic
or cultural differences across the EU. Nevertheless, the wording used to make health claims should be
truthful, clear, reliable and useful to the consumer in choosing a healthy diet.
In addition to fulfilling the general principles and conditions of the Regulation laid down in Article 3
and 5, Article 13(1)(a) stipulates that health claims shall describe or refer to "the role of a nutrient or
other substance in growth, development and the functions of the body". Therefore, the requirement to
EFSA Journal 2011;9(4):2078 17

describe or refer to the 'role' of a nutrient or substance in growth, development and the functions of
the body should be carefully considered.
The specificity of the wording is very important. Health claims such as "Substance X supports the
function of the joints" may not sufficiently do so, whereas a claim such as "Substance X helps
maintain the flexibility of the joints" would. In the first example of a claim it is unclear which of the
various functions of the joints is described or referred to contrary to the latter example which
specifies this by using the word "flexibility".
The clarity of the wording is very important. The guiding principle should be that the description or
reference to the role of the nutrient or other substance shall be clear and unambiguous and therefore
be specified to the extent possible i.e. descriptive words/ terms which can have multiple meanings
should be avoided. To this end, wordings like "strengthens your natural defences" or "contain
antioxidants" should be considered as well as "may" or "might" as opposed to words like
"contributes", "aids" or "helps".
In addition, for functions affected by a large number of dietary factors it should be considered
whether wordings such as "indispensable", "necessary", "essential" and "important" reflects the
strength of the scientific evidence.
Similar alternative wordings as mentioned above are used for claims relating to different relationships
between the various foods and health. It is not the intention of the regulator to adopt a detailed and
rigid list of claims where all possible wordings for the different claims are approved. Therefore, it is
not required that EFSA comments on each individual wording for each claim unless the wording is
strictly pertinent to a specific claim. It would be appreciated though that EFSA may consider and
comment generally on such elements relating to wording to ensure the compliance with the criteria
laid down in the Regulation.
In doing so the explanation provided for in recital 16 of the Regulation on the notion of the average
consumer should be recalled. In addition, such assessment should take into account the particular
perspective and/or knowledge in the target group of the claim, if such is indicated or implied.
TERMS OF REFERENCE
HEALTH CLAIMS OTHER THAN THOSE REFERRING TO THE REDUCTION OF DISEASE RISK AND TO
CHILDREN'S DEVELOPMENT AND HEALTH
EFSA should in particular consider, and provide advice on the following aspects:
 Whether adequate information is provided on the characteristics of the food pertinent to the
beneficial effect.
 Whether the beneficial effect of the food on the function is substantiated by generally
accepted scientific evidence by taking into account the totality of the available scientific data,
and by weighing the evidence. In this context EFSA is invited to comment on the nature and
quality of the totality of the evidence provided according to consistent criteria.
 The specific importance of the food for the claimed effect. For functions affected by a large
number of dietary factors whether a reference to a single food is scientifically pertinent.
In addition, EFSA should consider the claimed effect on the function, and provide advice on the
extent to which:
 the claimed effect of the food in the identified function is beneficial.

 a cause and effect relationship has been established between consumption of the food and the
claimed effect in humans and whether the magnitude of the effect is related to the quantity
EFSA Journal 2011;9(4):2078 18

consumed.
 where appropriate, the effect on the function is significant in relation to the quantity of the
food proposed to be consumed and if this quantity could reasonably be consumed as part of a
balanced diet.
 the specific study group(s) in which the evidence was obtained is representative of the target
population for which the claim is intended.
 the wordings used to express the claimed effect reflect the scientific evidence and complies
with the criteria laid down in the Regulation.
When considering these elements EFSA should also provide advice, when appropriate:
 on the appropriate application of Article 10 (2) (c) and (d) in the Regulation, which provides
for additional labelling requirements addressed to persons who should avoid using the food;
and/or warnings for products that are likely to present a health risk if consumed to excess.
EFSA Journal 2011;9(4):2078 19

APPENDIX B
EFSA DISCLAIMER
The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing
of the food/food constituent, a positive assessment of its safety, nor a decision on whether the
food/food constituent is, or is not, classified as foodstuffs. It should be noted that such an assessment
is not foreseen in the framework of Regulation (EC) No 1924/2006.
It should also be highlighted that the scope, the proposed wordings of the claims and the conditions of
use as proposed in the Consolidated List may be subject to changes, pending the outcome of the
authorisation procedure foreseen in Article 13(3) of Regulation (EC) No 1924/2006.
EFSA Journal 2011;9(4):2078 20

APPENDIX C
Table 1. Main entry health claims related to DHA and EPA, including conditions of use from similar
claims, as proposed in the Consolidated List.
ID Food or Food constituent Health Relationship Proposed wording

497 Fish oil Brain / cognitive function Omega-3 fatty acids can help
maintain:
- optimal brain function
- optimal cognitive function
Conditions of use
- 1.5g daily of EPA/DHA is recommended. Do not use if taking anti-coagulant medication
(e.g. warfarin or asprin)
No clarification provided by Member States

501 Long chain Omega 3 fatty acids Brain development, Long chain omega 3 fatty
cognitive development and acids contribute to mental and
cognitive function cognitive function
Clarification provided
- Long chain omega-3 fatty
acids are essential in normal
brain and mental
development.
- Long chain omega-3 fatty
acids are essential in normal
brain function
- DHA is the major fatty acid
constituent in mammalian
brain tissue
- Long chain Omega 3 fatty
acids are structural
components of nervose cells
and therefore necessary in
proper brain development.
Long chain fatty acids are
important for functional
maintenance of the CNS
- Improve cognitive
functions
- Maintain membrane fluidity
in brain cells.
Conditions of use
- Amount of consumption: mind. 300 mg langkettige n-3-Fettsäuren (EPA + DHA) / d
- Amount of consumption: 160 mg/Tag. Upper limit: 300. Other condition: Verzehrsmenge
für Schwangere und Stillende
EFSA Journal 2011;9(4):2078 21

- min 10% fat (product basis), max 33% SAFA (fat basis), max 2% TFA (fat basis); min
30mg VLC Omega 3 per 100g/ml and 100kcal (product basis), based on 15% of 200mg
GDA for VLC Omega3
- Minimum 500mg of LC-PUFA (AFSSA RDA value) per day
- Fruit drink that contain 18-30 mg/100 g, 45-75 mg/serving of omega-3 fatty acids.
- Omega 3 (EPA and DHA) At least 250 mg of total omega 3 (EPA+DHA).
508 Omega 3 fatty acids Eye health Show anti-inflammatory
properties
DHA is an important part of
the structure of the retina and
therefore plays a role in visual
development and normal eye
function
Conditions of use
- Richtiges Verhältnis von omega-3 und omega-6 Fettsäuren zugunsten der omega-3
Fettsäuren
- In Verbindung mit Vitamin C, E, B6, B12 und Zink
- Erwachsene. Amount of consumption: 160 Milligramm (mg). Period of consumption:
Dauersupplementierung. Upper limit: 3 Gramm (g). Other condition: betrifft nur DHA und
EPS (aus Fischöl)
- 125 - 500 mg
- 10mg lutein between 500 and 1000mg of Omega 3
510 DHA+EPA - long chain omega Eye, brain and heart health Omega 3 fatty acids support a
3 fatty acids healthy heart.
Conditions of use
- Minimum 0.3 g per 100g (15% of the 2 g RDI suggested by SCF)
No clarification provided by Member States
513 Long-chain omega-3 fatty acids Brain, eye and nerve “Long-chain Omega-3 fatty
EPA and DHA development and function acids EPA and DHA are
important for brain
development and function”
“Long-chain Omega-3 fatty
acids EPA and DHA support
normal development of the
brain, eyes and nerves”
“Long-chain Omega-3 fatty
acids EPA and DHA support
optiDHA, an omega-3 fatty
acid that is most concentrated
in the brain and retina,
supports normal cognitive and
EFSA Journal 2011;9(4):2078 22

visual function.”
“DHA is important for brain
development and function.”
“DHA supports normal
cognitive development.”
“DHA is important for normal
eye development and
function.”
“DHA supports visual
development and function.”
Conditions of use
- Erwachsene. Amount of consumption: 200 Milligramm (mg). Upper limit: 500 Milligramm
(mg). Other condition: DHA/EPA
- Daily consumption from single or multiple sources of at least 200 mg of DHA
- General population. Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed
as 200mg/day)
- Food supplement with 580mg of EPA fatty acids and 83 mg of DHA fatty acids in the daily
dose.
- Food supplement with 500-3000 mg of fish oil omega-3-fatty acids (EPA and DHA) in the
daily dose.
- 55 mg/day minimum
- General population. Minimum 15% RDI per 100g or 100kcal (RDI for EPA+DHA assumed
as 200mg/day)
514 Long-chain Omega-3 fatty Maternal Health; Pregnancy “Long-chain Omega-3 fatty
acids EPA and DHA and nursing acids EPA and DHA during
pregnancy support mum’s
DHA levels”“Long-chain
The omega-3 fatty acids Omega-3 fatty acids EPA and
EPA and DHA help sustain DHA during breast-feeding
pregnancy duration. supports DHA levels in breast
Consumption of long chain milk”“Long-chain Omega-3
omega-3 fatty acids increases fatty acids EPA and DHA
breast milk DHA levels support a healthy pregnancy"
during nursing.Consumption
of long chain omega-3 fatty
acids during pregnancy and
nursing increases the
mother’s DHA stores.
Maternal consumption of
EPA and DHA during
pregnancy may support
neural and visual
development in the unborn
baby.
Conditions of use
- General population. Minimum 15% RDI per 100g or 100kcal (RDI for EPA+DHA assumed
EFSA Journal 2011;9(4):2078 23

as 200mg/day)
- Minimum 15% RNI per 100g or 100kcal or Or amount to provide minimum 200 mg DHA/d
300-400mg DHA,
36-60mg EPA per day
General Population.
Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day)
Comments from Member States
No comment received from applicant in the Netherlands UK proposal: The omega-3 fatty acids
EPA and DHA help sustain pregnancy duration. Consumption of long chain omega-3 fatty
acids increases breast milk DHA levels during nursing.Consumption of long chain omega-3 fatty
acids during pregnancy and nursing increases the mother’s DHA stores. Maternal consumption
of EPA and DHA during pregnancy may support neural and visual development in the unborn
baby.
519 Long Chain Fatty Acids Brain and Eye Function May help maintain brain and
(EPA/DHA) eye function
Conditions of use
- 5-10ml per day
- Food supplement with 450-900 mg of EPA fatty acids and 200-400 mg of DHA fatty acids
in the daily dose.
- Food supplement with 580mg of EPA fatty acids and 83 mg of DHA fatty acids in the daily
dose.
- Food supplement with 500-3000mg of EPA fatty acids and DHA fatty acids in the daily
dose.
- Amount of consumption: 200mg/Tag. Other condition: min 10% fat (product basis), max
33% SAFA (fat basis), max 2% TFA (fat basis); min 30mg VLC Omega 3 per 100g/ml and
100kcal (product basis), based on 15% of 200mg GDA for VLC Omega3
521 Long Chain Fatty Acids Brain Function Supplementation of omega 3
(EPA/DHA) oils may help maintain mental
function during pregnancy and
lactation.
Supports cognitive and
learning function during early
life.
Conditions of use
- Senioren. Amount of consumption: 720 mg/Tag. Upper limit: 1720 Milligramm (mg)
- 110-220 mg DHA entspricht 290-580 mg DHA reiches Algenöl
- Amount of consumption: 55 mg/Tag. Upper limit: 160
525 Omega-3 fish body oil - PUFAs Skin and digestive tract May help maintain a healthy
epithelial cells maintenance digestive system Gentle on the
stomach Appearance of skin,
EFSA Journal 2011;9(4):2078 24

Clarification provided healthy looking skin, a part of

your daily skin care routine,
Helps to maintain fluidity of helps maintain a good
cell membranes thus helping complexion.
to increase the moisture
content of epithelial tissue
(which includes skin and gut
mucosa). Increases moisture
content of skin cells thus
improving the appearance of
dry skin. Increases elasticity
of epithelial tissue.Used by
the body to produce certain
prostaglandins (series 1 & 3)
that play a role in reducing
inflammation Improves the
structure of villi hence play a
role in improving absorption
of nutrients. Maintains
structure of the epithelial
layer of gastrointestinal
mucosa therefore can help to
improve ability to absorb
nutrients. Increase surface
area and thickness of cells
lining the intestines resulting
in enhanced absorption of
nutrients.Plays a role in
mitigating the damaging
effects associated with
excessive saturated fat intake
by readdressing the
balance/Plays a role in
mitigating against potential
damage caused by excessive
levels of saturated
fat.Increase the time food
spends in the stomach
resulting in increased time
for breakdown thus
improved digestion.
Conditions of use
- Food supplement with 500-3000mg of EPA fatty acids and DHA fatty acids in the daily dose
- Usual consumption as traditional foodstuff in a normal diet.. 340mg total Omega 3 fatty acids
daily.
529 Omega 3 fatty acids Eye health DHA is an important
component of the retina and
(DHA/EPA)
helps to maintain visual
faculty
EFSA Journal 2011;9(4):2078 25

Conditions of use
- 150-350mg DHA, 36-100mg EPA per day. 125 - 500mg omega-3 fatty acids per day.
- Jugendliche, Erwachsene. Amount of consumption: 50 – 150
534 Fish oil 1 n-3 are essential fatty acids Fish oil helps maintain brain
and have critical roles in the function
N-3 (EPA, DHA)
membrane structure and as
Fish oil helps maintain vigour
precursors of eicosanoids
Fish oil helps maintain mental
strength and energy
Fish oil is important for brain
Fish oil is an important
function and improves
component of the brain
memory and attention.
Fish oil helps/contribute to
maintain a healthy memory
Conditions of use
- Minimum 1g fish oil equal to on average 320 EPA and 220 DHA
- Säuglingsanfangsnahrung–DHA mindestens 0,2% von Gesamtfettsäuren, Verhältnis
ARA/DHA mindestens 1 ––Frühgeborenennahrung–DHA mindestens 0,2% von
Gesamtfettsäuren, Verhältnis ARA/DHA mindestens 1
536 EPA and DHA Omega-3 fatty Mood Omega-3 EPA and DHA
acids support normal emotional
wellbeing
Regular Omega-3 intake can
help reduce how often you
feel sad and low
Conditions of use
- General Population. Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA
assumed as 200mg/day)
- Food supplement with 450-900 mg of EPA and 200-400 mg of DHA fatty acids derived
from fish oil in the daily dose.
- Equivalent of 200mg to 1,2g/d of Long Chain Poly Unsaturated Fatty Acids (LC-PUFA)
omega 3 (EPA and/or DHA)
- DHA: 0,8 g to 1,8 g per day or/and EPA: 0,9 g to 1,6 g per day or ALA: 9 g per day.
- Omega 3 (EPA and DHA) At least 300 mg per day of total essential fatty acids (EPA +
DHA)
539 Omega-3 fatty acids (incl. To fulfil increased omega-3 To fulfil increased omega-3
DHA) fatty acids need during fatty acids need during
pregnancy pregnancy
To fulfil increased omega-3
fatty acids need during
pregnancy, necessary to
EFSA Journal 2011;9(4):2078 26

cover the increased

metabolism and tissue
growth
Conditions of use
- 125 - 500 mg
- 125 - 500 mg
540 Omega-3 fatty acids (incl. Support of human It supports an optimal brain
DHA) neurodevelopment development
Clarification provided It supports human
neurodevelopment,
It supports normal brain and
nerves structure and Plays an important role in the
function, being integral part development of brain and
of the nervous system cells. nerves,
DHA is an important Contributes to normal brain,
component of brain and nerve and visual development.
nerve structures. It
specifically plays an
important role in the
development and
maintenance of brain and
nerves and contributes to
normal brain, nerve and
visual development.
Conditions of use
- 125 - 500 mg
688 DHA+EPA - long chain omega Eye, brain and heart health Omega 3 fatty acids support a
3 fatty acids healthy heart.
Eye health: Omega-3 /
Omega-6-fatty are molecule
precursor affecting the
production and quality of
tear film composition (by
affecting lipid profiles of
meibomian gland secretions)
Conditions of use
- Jugendliche, Erwachsene. Amount of consumption: 200 – 600 .
- In Verbindung mit Vitamin C, E, B6, B12 und Zink
- Richtiges Verhältnis von omega-3 und omega-6 Fettsäuren zugunsten der omega-3
Fettsäuren
1323 Poisson sauvage Système nerveux Contribue à un bon équilibre
nerveux
Réduction des risques liés au
EFSA Journal 2011;9(4):2078 27

dévellopement de la maladie Favorise un bon équilibre

d'Alzheimer mental chez les personnes
âgées
Pour garder une bonne
mémoire
Pour conserver une bonne
mémoire
Conditions of use
- Huile 6 x 500mg/jour
1360 Name of Food product: Health benefits of food: Exact wording of claim as it
Dairygold Omega-3 Spread Dairygold Omega-3 spread appears on product: Front of
contain omeag- 3 fatty acids Pack: Dairygold Omega 3.
Description of food in terms of
(EPA & DHA) which may Low fat (38%) spread with
food legislation categories:
have a beneficial role to play omega 3 for healthy hearts*
food not covered by specific
in the functioning of the and minds. (Heart Health
food legislation
brain and can help maintain a Claim submitted separately).
Was food on Irish market healthy heart
Back of pack: Omega 3 fatty
before 1st July 2007: Yes
Do benefits relate to a acids (EPA & DHA) are
disease risk factor: No important nutrients for brain
function and therefore may
Target group: All of the
enhance learning and
general population including
concentration.
children and adults
Examples of any alternative
wording that may be used in
relation to claim: Packaging
contains the omega symbol but
this is not directly implicit of
the health claim.
Is claim a picture: No
Conditions of use
- Number of nutrients/other substances that are essential to claimed effect: 1. Names of
nutrient/other substances and Quantity in Average daily serving: 148 miligrams Omega-3
fatty acids. Weight of average daily food serving: 148 miligram(s). Daily amount to be
consumed to produce claimed effect: 450 miligram(s). Number of food portions this
equates to in everyday food portions: 3. Are there factors that could interfere with
bioavailability: Yes. Please give reason: Omega-3 fattty acids are derived from fish oil and
are susceptible to oxidation. Due to the lipid content of this food matrix, the EPA and DHA
content are relatively stable and are unlikely to oxidize. However, over exposure of the
spread to atmospheric oxygen for long periods should be avoided. Length of time after
consumption for claimed effect to become apparent: Cognitive improvements have been
reported in children following 3 months supplementation with Omega-3 fatty acids. Is there
a limit to the amount of food which should be consumed in order to avoid adverse health
effects: No. Where applicable outline nutritional composition (g per 100g) of food: Total
Fat: 38.00, Saturated Fat: 11.00, Trans Fat: .00, Sugar: .10, Salt: 1.50, Sodium:
.60. Other conditions for use: Long chain PUFA's (Omega 3 & 6 fatty acids) from fish oil
are well documented to have an important role to play in the functioning of the brain.
Omega fatty acids comprise one third of the total fatty acids in brain tissue and are thought
to have a myriad of functions including maintaining membrane fluidity which is turn affects
EFSA Journal 2011;9(4):2078 28

neural signaling. n-3 PUFA's also affect neurotransmission in the frontal lobes of the brain.
It is well recognised that western diets are deficient in Omega-3. Diarygold Omega 3 spread
contributes a rich, readily available, source of omega-3 fatty acids to the diet. 3 x 10g
portions will provide one third of the recommended daily intake of Omega 3 fatty acids
(RDI 450mg). The remainder should be achieved through a healthy balanced diet including
at least 2-3 portions of fish per week, one of which should be oily.
2905 Long-chain omega-3 (n-3) Building block for lipids in DHA is an important part of
polyunsaturated fatty acids (LC the retina’s photoreceptors; the structure of the retina and,
omega-3 PUFA, LC n-3 Eye Health therefore, plays a role in visual
PUFA) or docosahexaenoic development and normal eye
acid or eicosapentaenoic acid function and healthy vision
or omega-3 fish oils
Conditions of use
- Applicable to adults and children
4294 fish oil (EPA, DHA) Membranes cell structure Contributes to the normal
membrane cell structure (brain
and retina cell)
Conditions of use
- Dose: 24mg/day of fish oil Target group: old people, people having slight fall of
concentration and memorization
4295 fish oil (EPA, DHA) Membranes cell structure Contributes to thin the blood
Conditions of use
- Dose: 24mg/day of fish oil Target group: old people, people having slight fall of
concentration and memorization
4688 Omega 3-Fatty acids containing Anti-inflammatory action Function in the synthesis of
eicosapentaenoic acid-EPA and due to EPA and DHA. prostaglandins.
docosahexaenoic acid (DHA).
Helps in inflammatory,
rheumatismal disease.
Conditions of use
- Adults and children: 500 - 1000 mg Omega 3 per day.
4719 Pure salmon oil 500 mg. D Blood Health Supports the normal level of
alpha tocopherol10 mg.-cps blood cholesterol.
Conditions of use
- 2 capsules/ day - 1000 mg. /day, min. 90 days
EFSA Journal 2011;9(4):2078 29

GLOSSARY AND ABBREVIATIONS

AHRQ Agency for healthcare research and quality
DHA Docosahexaenoic acid
EPA Eicosapentaenoic acid
LCPUFA Long-chain polyunsaturated fatty acids
POMS Profile of mood states
RCT Randomised controlled trial
EFSA Journal 2011;9(4):2078 30

DHA and EPA - Maintenance of Normal Brain Function

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DHA and EPA - Maintenance of Normal Brain Function

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EFSA Journal 2011;9(4):2078

Scientific Opinion on the substantiation of health claims related to

European Food Safety Authority (EFSA), Parma, Italy

© European Food Safety Authority, 2011

Brain, eye and nerve development

Maintenance of normal brain function

Maintenance of normal vision

Maintenance of normal cardiac function

EFSA Journal 2011;9(4):2078 2

“To fulfil increased omega-3 fatty acids need during pregnancy”

“Skin and digestive tract epithelial cells maintenance”

“Membranes cell structure”

EFSA Journal 2011;9(4):2078 3

Maintenance of normal blood LDL-cholesterol concentrations

EFSA Journal 2011;9(4):2078 4

EFSA Journal 2011;9(4):2078 5

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

EFSA Journal 2011;9(4):2078 6

INFORMATION AS PROVIDED IN THE CONSOLIDATED LIST

1. Characterisation of the food/constituent

2. Relevance of the claimed effect to human health

EFSA Journal 2011;9(4):2078 7

2.4. Maintenance of normal cardiac function (ID 510, 688, 1360)

2.5. “Maternal health; pregnancy and nursing” (ID 514)

EFSA Journal 2011;9(4):2078 8

2.8. Enhancement of mood (ID 536)

2.9. “Membranes cell structure” (ID 4295)

2.10. “Anti-inflammatory action” (ID 4688)

EFSA Journal 2011;9(4):2078 9

2.11. Maintenance of normal blood LDL-cholesterol concentrations (ID 4719)

3. Scientific substantiation of the claimed effect

3.1. Enhancement of mood (ID 536)

EFSA Journal 2011;9(4):2078 10

Brain, eye and nerve development (ID 501, 513, 540)

The claimed effects are “brain/cognitive function”, “brain development, cognitive

Maintenance of normal cardiac function (ID 510, 688, 1360)

“Maternal health; pregnancy and nursing” (ID 514)

EFSA Journal 2011;9(4):2078 12

“Skin and digestive tract epithelial cells maintenance” (ID 525)

Enhancement of mood (ID 536)

“Membranes cell structure” (ID 4295)

“Anti-inflammatory action” (ID 4688)

Reduction of inflammation in the context of inflammatory diseases is a therapeutic target for

Maintenance of normal blood LDL-cholesterol concentrations (ID 4719)

DOCUMENTATION PROVIDED TO EFSA

EFSA Journal 2011;9(4):2078 13

The full list of supporting references as provided to EFSA is available on:

EFSA Journal 2011;9(4):2078 14

EFSA Journal 2011;9(4):2078 15

BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

(i) based on generally accepted scientific evidence; and

ISSUES THAT NEED TO BE CONSIDERED

IMPORTANCE AND PERTINENCE OF THE FOOD7

EFSA Journal 2011;9(4):2078 16

SUBSTANTIATION OF CLAIMS BY GENERALLY ACCEPTABLE SCIENTIFIC EVIDENCE

WORDING OF HEALTH CLAIMS

EFSA Journal 2011;9(4):2078 17

 the claimed effect of the food in the identified function is beneficial.

EFSA Journal 2011;9(4):2078 18

EFSA Journal 2011;9(4):2078 19

EFSA Journal 2011;9(4):2078 20

ID Food or Food constituent Health Relationship Proposed wording